Regulatory

Bujar et al 2020 – Documentation of Quality Decision-Making Practices

Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]

2021-01-19T09:48:15+00:00June 18th, 2020|Tags: , |

Sithole et al 2020 – Evaluating the success of ZaZiBoNa

The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]

2021-01-19T09:39:49+00:00May 19th, 2020|Tags: , , |

CIRS RD Briefing 75 – Emergency Use Pathways (EUPs)

It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these [...]

2021-01-19T09:27:54+00:00May 6th, 2020|Tags: |

Keyter et al 2020 – Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations [...]

2021-01-19T09:26:22+00:00March 25th, 2020|Tags: , , |

Mashaki Ceyhan et al 2020 – Patients’ perspectives of the pharmaceutical regulatory and reimbursement system in Istanbul, Turkey

The aim of this study was to explore patients’ knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to access to new [...]

2021-03-29T13:33:34+00:00February 6th, 2020|Tags: , , , |

Koyuncu et al 2020 – Evaluation of the performance of the Turkish regulatory agency: recommendations for improved patients’ access to medicines

Background: This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since [...]

2021-03-29T13:33:50+00:00February 3rd, 2020|Tags: , |
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